Comparison of Two New Silicone Hydrogel Multifocal Products

NCT00823615 | Completed Results

• 1 other identifier: P-319-C-005 sub 7
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this trial is to compare the performance of two multifocal contact lenses.

Conditions

Presbyopia

Outcome Measures

Primary Outcomes (2)

• Corrected Distance Binocular Visual Measurement in Normal Illumination Reported as Binocular Distance Visual Acuity

  Tested while reading charts distant to the subject with both eyes together in normal lighting. This outcome is measured in logMAR units (logarithm of the minimum angle of resolution). A logMAR acuity of 0.0 equates to 20/20 Snellen acuity and is considered normal. Positive logMAR values indicate poorer vision and negative values denote better visual acuity.

  After 1 week of wear

• Corrected Near Binocular Visual Measurement in Normal Illumination Reported as Binocular Near Visual Acuity

  Tested while reading charts at 40 cm with both eyes together in normal lighting. This outcome is measured in logMAR units (logarithm of the minimum angle of resolution). A logMAR acuity of 0.0 equates to 20/20 Snellen acuity and is considered normal. Positive logMAR values indicate poorer vision and negative values denote better visual acuity.

  After 1 week of wear

Study Arms (2)

Lotrafilcon B / Senofilcon A

OTHER

Lotrafilcon B, followed by Senofilcon A

Device: Lotrafilcon B multifocal contact lens; Device: Senofilcon A multifocal contact lens

Senofilcon A / Lotrafilcon B

OTHER

Senofilcon A, followed by Lotrafilcon B

Device: Lotrafilcon B multifocal contact lens; Device: Senofilcon A multifocal contact lens

Interventions

Lotrafilcon B multifocal contact lens DEVICE

Silicone hydrogel, soft, multifocal contact lens for daily wear use

Lotrafilcon B / Senofilcon A; Senofilcon A / Lotrafilcon B

Senofilcon A multifocal contact lens DEVICE

Silicone hydrogel, soft, multifocal contact lens for daily wear use

Lotrafilcon B / Senofilcon A; Senofilcon A / Lotrafilcon B

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 35 years of age
• Best-corrected visual acuity of at least 20/40 in each eye.
• Spectacle add between +0.75D and +1.50D (inclusive).
• Able to be fit in available study sphere powers (-0.50 to -5.50D).
• Currently wearing soft contact lenses at least 5 days a week.

You may not qualify if:

• Requires concurrent ocular medication.
• Eye injury or surgery within twelve weeks immediately prior to enrollment.
• Currently enrolled in an ophthalmic Clinical Trial.
• Evidence of systemic or ocular abnormality, infection or disease likely to affect successful wear of contact lenses or use of their accessory solutions.
• Previous refractive surgery.
• Astigmatism \> 1.00D.
• Currently wearing ACUVUE OASYS for PRESBYOPIA.

Sponsors & Collaborators

• CIBA VISION: lead

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Priya Janakiraman, OD, FAAO / Head, Global Clinical Affairs
• Organization: CIBA VISION

priya.janakiraman@cibavision.com

1-800-241-7629

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2009
• First Posted: January 15, 2009
• Study Start: December 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: June 29, 2012
• Results First Posted: October 29, 2010

Record last verified: 2012-01